# K940168: Diagnostic II Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Ep Technologies, Inc.
- Decided: Jul 27, 1994 after 201 days
- Product code: DRF (Catheter, Electrode Recording, Or Probe, Electrode Recording)
- Device class: 2
- Regulation: 21 CFR 870.1220
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
11 later devices descend from it; 3 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K012708: Electrophysiology Catheter (2002), 5 descendants of its own
- K081576: Blazer DX-20 Diagnostic Catheter (2009), 3 descendants of its own
- K211375: Blazer™ Dx-20 Bidirectional Steerable Diagnostic Catheter (2021), 1 descendant of its own
- K043393: Reprocessed EP Technologies Electrophysiology Catheters (2005), 1 descendant of its own
- K232651: BLAZER™ Dx-20 Bidirectional Steerable Diagnostic Catheter (2023), 0 descendants of its own

Source page: https://510kreport.com/device/K940168
Methodology: https://510kreport.com/methodology